Lipid-lowering Injectable Antibodies: The Next Big Thing?

LDL-cholesterol reductions of up to 85% were seen after the first week of therapy in the hardest-to-treat patients—this remarkable finding related to experimental PCKS-9 inhibitors topped a roster of late-breaking clinical trial results at the American Heart Association’s 2012 Scientific Sessions, held in Los Angeles in early November. In this podcast, Dr Robert Giugliano, principal investigator of the LAPLACE-TIMI 57 trial, which studied PCSK-9 inhibition in patients with hypercholesterolemia, highlights his team’s results as well as findings from other key studies that are looking at the impact of anti-PCSK-9 monoclonal antibodies on LDL-cholesterol. The results are particularly promising in hard-to-treat populations, including patients unable to reach lipid goals on current statin therapy, patients who are statin-intolerant, and patients with genetic hypercholesterolemia. CardiologyNow host Dr Payal Kohli interviews Dr Giugliano, here.

Find additional details on studies discussed in this podcast, here:

PCSK-9 inhibitor plus statin

• LAPLACE-TIMI 57—Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia: a randomised, placebo-controlled, dose-ranging, phase 2 study.

PCSK-9 inhibitor as monotherapy

• MENDEL—Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia: a randomised, double-blind, placebo-controlled, phase 2 study.

PCSK-9 inhibitor to treat familial hypercholesterolemia

• RUTHERFORD—Reduction of LDL-C with PCSK9 inhibition in heterozygous familial hypercholesterolemia disorder: results from a phase 2, randomized, double-blind, placebo-controlled trial.

-- AHA Summary Slide

PCSK-9 inhibitor in statin-intolerant patients

• GAUSS—Goal achievement after utilizing an anti-PCSK9 antibody in statin intolerant subjects: interim results from a randomized, double-blind, placebo-controlled study.

-- AHA Summary Slide